Background: There are limited data on parental perception of infant participation in minimal risk and minor\nincrease above minimal risk research focusing on the NICU population. The study objective was to assess parental\nand NICU staff perceptions concerning minimal risk and minor increase above minimal risk in the NICU setting.\nMethods: Parents of infants and NICU staff were presented with a combination of 4 infant scenarios and 5\nhypothetical research procedures. These assessed participants� willingness to allow their infant to participate in\nresearch and their attitude towards obligation to assist future children. Linear and hierarchal linear models analyzed\nthe association and interaction effects on the likelihood to consent to research procedures.\nResults: Sixty parents and 30 NICU staff members were surveyed. Parents� acceptability for each of the five research\nprocedures ranged from 31 % to 83 %. Parent gender, age, race/ethnicity, insurance, education and history of\nprevious child in the NICU were not associated with the likelihood to consent to the research procedures.\nAcceptability for each of the five research procedures among NICU staff ranged from 19 % to 98 %. There were no\nsignificant differences between NICU staff�s and parents� responses for 4 of 5 research procedures. A minority of\nparents and nurses (38.3 % and 40 % respectively), compared to a majority of physicians (66.7 %), agreed or\nstrongly agreed that parents have a responsibility to involve their children in low risk medical research in order to\nhelp future children, even if this would not help their own child. Lower agreement with obligation to help future\nchildren (p < 0.01) and higher education (p = 0.01) were associated with a decreased likelihood to consent to\nresearch procedures.\nConclusion: In our study population, common NICU-related research procedures were considered appropriate and\nacceptable to a diverse group of NICU parents representing a wide range of race/ethnic and socioeconomic strata.\nCurrent regulations guiding informed consent for minimal and minor increase over minimal risk research in the\nNICU environment appear ethically consistent with a diverse group of parents and providers.
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